Liberation From Acute Dialysis

  • STATUS
    Recruiting
  • days left to enroll
    53
  • participants needed
    220
  • sponsor
    University of California, San Francisco
Updated on 19 February 2024
vasopressor
acute renal failure
dialysis
glomerular filtration rate
renal injury
liberate
vasoconstrictor
renal replacement
acute tubular necrosis
intermittent hemodialysis
acute renal disease
injury kidney

Summary

The goal of the LIBERATE-D clinical trial is to improve outcomes for patients recovering from dialysis-requiring acute kidney injury (AKI-D). The impact of a conservative dialysis strategy compared to standard clinical practice of thrice-weekly dialysis will be examined to help generate knowledge for how to guide delivery of dialysis to facilitate renal recovery.

Description

Dialysis-requiring acute kidney injury (AKI-D) is a devastating complication among hospitalized patients for which there are no treatments other than supportive care. Recovery of sufficient renal function to stop dialysis is an unequivocally important clinical and patient-oriented outcome. Shortening dialysis duration and increasing the number of AKI-D patients who recover would have a major clinical, public health and cost-saving impact. However, there is currently no evidence to guide the delivery of dialysis to facilitate recovery. The investigators hypothesize that in patients who have AKI-D and who are hemodynamically stable, a conservative dialysis strategy--in which hemodialysis is not continued unless specific metabolic or clinical indications for renal replacement therapy (RRT) are present--will improve the likelihood of renal recovery compared with the current standard clinical practice of thrice-weekly intermittent dialysis. The investigators have conducted a pilot clinical trial to demonstrate the feasibility of this approach. The investigators propose here a 2-center randomized controlled trial to test a conservative dialysis strategy in a larger AKI-D population (N = 220).

Details
Condition Renal Failure, Renal Failure, Acute renal failure, Kidney; Disease, Acute, Dialysis Related Complication
Age 18-100 years
Treatment Dialysis
Clinical Study IdentifierNCT04218370
SponsorUniversity of California, San Francisco
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

years of age
Inpatient with AKI-D (intermittent hemodialysis or continuous renal replacement therapy received on at least one calendar day) at least partially due t acute tubular necrosis per the clinical nephrology team
Hemodynamic stability: not requiring vasopressor support and with planned intermittent dialysis
Baseline estimated glomerular filtration rate (eGFR) 15 mL/min/1.73 m2

Exclusion Criteria

Nontraditional indication for dialysis (end-stage liver disease awaiting transplantation, fulminant hepatic failure, intoxication)
Complete nephrectomy as cause of AKI-D
Kidney transplant during index hospitalization
Dialysis > 3 months
Decompensated heart failure requiring left ventricular assist device or continuous inotropic support
Mechanical ventilation via endotracheal tube
Hypoxemia requiring significant oxygen support: >5 liters/min via nasal cannula or equivalent via face mask/tracheostomy mask to maintain oxygen saturation > 95%, or requiring fraction of inspired oxygen >50% in patients with tracheostomy requiring invasive or non-invasive ventilation
Unable to consent and no surrogate decisionmaker available
Pregnant
Prisoner
Clinical team declines to allow study participation
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